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LYPHOMED's GENERIC CEFAZOLIN IS ONE OF THREE FIRST-TIME ANDA

Executive Summary

LYPHOMED's GENERIC CEFAZOLIN IS ONE OF THREE FIRST-TIME ANDA approvals received by the firm on Nov. 17. In addition to cefazolin, (Lilly's Kefzol and SmithKline's Ancef), LyphoMed received ANDA approval for the antibiotic cephapirin (marketed by Bristol as Cefadyl) and the neuroleptic droperidol (marketed by Janssen as Inapsine). LyphoMed is the first company to receive ANDA approval for generic versions of cefazolin and cephapirin in finished dosage forms. Other companies, however, have received approval for the bulk formulations of the first-generation cephalosporins. LyphoMed's Invenex Labs division received approval for cefazolin sodium in a .5 g/10 ml vial, a 1 g/10 ml vial, a .5 g/100 ml piggyback vial, a 1 g/100 ml piggyback vial, and a 10 g pharmacy bulk package. LyphoMed said it will launch cefazolin when the patent expires in mid-1987. The Invenex division received approval for cephapirin sodium in 500 mg/ml vials; 1, 2 and 4 g/100 ml piggyback vials; and 20 g/100 ml pharmacy bulk vials. The company said a launch date has not been set. LyphoMed's droperidol approvals were for 2.5 mg/ml in 2 and 5 ml single-dose vials and, with preservative, in 2 and 10 vials. LyphoMed plans to introduce the neuroleptic in December.
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